A Study of AK0529 in Infants Hospitalized With RSV

Shanghai Ark Biopharmaceutical

Status and phase

Terminated

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Treatments

Drug: AK0529

Study type

Interventional

Funder types

Industry

Identifiers

NCT02460016

AK0529-1002

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).

Full description

This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.

Enrollment

1 patient

Sex

All

Ages

1 to 24 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
Diagnosis of RSV infection by virological.
Subject must weigh >3 kg at screening.
Must have provided written informed consent for the subject to participate.
For patients aged <12 months, and occipitofrontal head circumference (OFHC) within the normal range for age and gender.

Exclusion criteria

The subject has taken, is currently taking or requires any restricted medications.
Subject is known to be HIV-positive (or the mother, if the potential subject is a child aged <6 months).
Participation in an investigational drug or device study within 30 days prior to the date of screening.
Requires vasopressors or inotropic support at the time of enrollment.
Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrollment.
Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
Left to right shunt meriting corrective therapy.